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| Name | Class |
|---|---|
| University of Public Health, Myanmar | OTHER |
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The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.
In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.
They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.
Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.
The proportion of patients reaching SVR will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir/Daclatasvir | Other | standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCV point of care machine | Device | Xpert HCV Assay performed on the GeneXpert point of care machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) | To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring. | 12 weeks post completion of commenced treatment |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to participate in this study.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirby Institute, University of New South Wales Australia | Sydney | New South Wales | 2052 | Australia |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Sequential Assignment
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |